FDA Adverse Event
Injury
Summary report: N
SHORT 5MM SINGLE USE ABS FIX DEV 20 TACK
MDR report key: 4215332
·
Received October 30, 2014
Report
- Report Number
- 1219930-2014-00986
- Event Type
- Injury
- Date Received
- October 30, 2014
- Date of Event
- March 28, 2011
- Report Date
- October 13, 2014
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL A DIVISON
- Product Code
- OWT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT HAD HERNIA REPAIRED WITH BARD COMPOSITE MESH (NON-COVIDIEN).TACKS DID NOT HOLD THE MESH IN PLACE. THE PATIENT SAID THAT SHE EXPERIENCED PAIN POST OPERATIVELY. REOPERATION TO REPLACE/REPAIR MESH ON (B)(6) 2012. PATIENT WAS TOLD BY HER 2ND SURGEON (DR. (B)(6)THAT THE ISSUE WAS NOT WITH THE MESH, BUT THE TACKER USED TO HOLD IT IN PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 695011 | SHORT 5MM SINGLE USE ABS FIX DEV 20 TACK | SHORT 5MM SINGLE | OWT | COVIDIEN, FORMERLY US SURGICAL A DIVISON | ABSTACK20S | NOT AVAILABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |